Medical Writer 2057623
Location: Cambridge, MA (Hybrid)
Science/ Focus: Cell Therapy
Job Overview: The Medical Writer will create and oversee critical documents for regulatory filings, clinical studies, and publications, including protocols, reports, consent forms, and manuscripts.
Primary Job Responsibilities:

• Lead and write clinical documents like protocols, reports, brochures, and regulatory submissions.

• Lead meetings for document development and review.

• Maintain writing timelines, standards, and processes for clinical and regulatory documents.

• Review statistical plans for data alignment in reports and summaries.

Primary Job Requirements:

• Degree in life sciences or health discipline (Bachelors, Masters, PharmD, or Ph.D.). with a minimum 4 years of medical writing experience in pharmaceutical or biotech sectors.

• Knowledge of drug development, clinical operations, and regulatory interactions.

• Familiarity with ICH guidelines, GxP, and related regulatory standards.

• Proven expertise as lead author on standard clinical documents.

About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystems.com or 844-463-6178.